New Pylarify TruVu Formulation Approved by FDA

On March 6, 2026, the US Food and Drug Administration (FDA) approved Lantheus Holdings’ Pylarify TruVu™ (piflufolastat F 18) injection for positron emission tomography (PET) imaging of prostate‑specific membrane antigen (PSMA)–positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy or suspected recurrence based on elevated prostate-specific antigen (PSA) levels. Pylarify TruVu is a new, higher-concentration, stable formulation of the company’s PSMA‑PET imaging agent, designed to enable larger manufacturing batches, improve stability, and support broader geographic distribution to expand patient access. The new formulation is expected to offer similar safety and effectiveness to the original Pylarify while improving supply flexibility. Commercial launch is anticipated in 4Q 2026. Full prescribing information can be found here.

Sotyktu Gets Psoriatic Arthritis Indication

The FDA approved Bristol Myers Squibb’s Sotyktu^® (deucravacitinib), an oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults who have active psoriatic arthritis (PsA) on March 6, 2026. This approval expands Sotyktu’s label beyond its prior indication in moderate‑to‑severe plaque psoriasis and marks the first TYK2 inhibitor approved for psoriatic arthritis. Approval was based on positive results from the phase III POETYK PsA‑1 and POETYK PsA‑2 trials, in which 54% of patients treated with Sotyktu achieved an American College of Rheumatology (ACR) 20 response at week 16, compared with 34%-39% in those treated with placebo. Key secondary endpoints, including minimal disease activity, also favored Sotyktu. The safety profile was consistent with prior studies, with common adverse events including upper respiratory infections, acne, and oral ulcers. Sotyktu is administered orally once daily at a 6mg dose, offering a non‑injectable option for patients with inflammatory joint and skin disease. Here is the updated prescribing information.

FDA Approves First Therapy for Cerebral Folate Transport Deficiency

On March 10, 2026, the FDA approved leucovorin calcium tablets, a synthetic form of vitamin B9 (folate), as the first approved treatment for cerebral folate transport deficiency (CFD) in adult and pediatric patients who have a confirmed folate receptor 1 (FOLR1) gene variant (CFD-FOLR1). The oral therapy addresses impaired transport of folate into the brain, a mechanism underlying severe neurologic manifestations such as developmental delay, seizures, and movement disorders that can overlap with autism‑like features. Approval was supported by a systematic review of published case reports and mechanistic evidence, rather than randomized trials. A review of six published case reports and literature reviews through 2024 identified 27 patients treated with oral leucovorin, with 24 showing improvements that included fewer or less severe seizures and gains in motor function, communication, and/or behavior. The indication does not extend to autism broadly, as the FDA cited insufficient evidence for that population. Originally marketed as Wellcovorin® (GSK), it was initially approved for counteracting the toxic effects of certain ​cancer drugs, like methotrexate, that block the body’s use of folate. It is administered orally and should be initiated at 1 to 2mg/kg/day, with dosing adjusted by body weight to a maximum of 8.5mg/kg/day in patients weighing less than 40kg and up to 330mg/day in those weighing 40kg or more, with the total daily dose given once daily or divided into as many as six doses. Adverse effects may include itchy skin, rash, hives, difficulty breathing, chills, and impaired temperature regulation. This approval allows generic leucovorin products to carry the new indication, and updated prescribing information is available here.

Ipsen Voluntarily Withdraws Tazverik

On March 9, 2026, Ipsen initiated a voluntary withdrawal of Tazverik^® (tazemetostat) oral tablets from the US market, effective immediately, for all approved indications. The withdrawal was prompted by newly identified safety data from an ongoing study that demonstrated an imbalance in hematologic secondary malignancies, including cases suggestive of myelodysplastic syndrome (MDS) and acute leukemia. Tazverik is a methyltransferase inhibitor that received accelerated approval in 2020 for the treatment of adult patients who have relapsed or refractory follicular lymphoma (R/R FL) whose tumors are enhancer of zeste homolog 2 (EZH2) mutation positive and who have received at least two prior systemic therapies, as well as for adult patients who have R/R FL with no satisfactory alternative treatment options and adult and pediatric patients aged 16 years and older who have metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Following an ad hoc review by an Independent Data Monitoring Committee (IDMC), Ipsen determined that the potential risks of continued treatment may outweigh the clinical benefit in this setting and advised clinicians to immediately discontinue treatment and transition patients to alternative therapies, concurrent with trial enrollment suspension and market withdrawal across all indications. Ipsen stated that it will continue to evaluate the safety data in collaboration with regulatory authorities and will provide updates as additional information becomes available.

Arexvy Approved in Adults at High-Risk of RSV

On March 13, 2026, the FDA approved GSK’s Arexvy^® (respiratory syncytial virus (RSV) vaccine, adjuvanted) for the prevention of RSV‑related lower respiratory tract disease (LRTD) in adults aged 18 years – 49 years at increased risk. This expands the previous approval for adults aged 60 years and older, and adults 50 years – 59 years at increased risk. GSK estimates that 21 million adults under 50 years of age have at least one risk factor for severe RSV infection. Approval was supported by a non‑inferior immune response compared with adults aged 60 years and older. The safety profile was consistent with prior studies, with the most common adverse events including injection‑site pain, fatigue, muscle pain, headache, and joint pain, typically occurring within four days of vaccination. Two other RSV vaccines are approved for use on the US market, including Pfizer’s Abrysvo^® and Moderna’s mRESVIA^®. Both Abrysvo and mRESVIA are approved for adults 60 years and older and for adults ages 18–59 years with high‑risk conditions, while Abrysvo is the only RSV vaccine approved for use during pregnancy to help protect infants from lower respiratory tract disease during the first six months of life. Updated prescribing information is here.